NIH Tech Transfer

Investigator Attestation for MTAs, DTAs, DUAs & RCAs

If an investigator is sharing or receiving specimens or data for research purposes as part of executing a Material Transfer Agreement (MTA), Data Transfer Agreement (DTA), Data Use Agreement (DUA), or Research Collaboration Agreement (RCA), he or she is required to complete the Investigator Attestation above and submit it to his or her Tech Transfer contact.  The form must be signed either by the investigator or an OHSRP staff person.

This form was implemented to ensure that NIH investigators are complying with applicable human subjects research protections requirements in association with the transfer and use of human specimens and/or data.  For example:

• When the specimens and/or data were collected under an NIH IRB approved protocol, the investigator must comply with the terms in the original consent form regarding sharing and future research.
• When the transfer will result in the NIH investigator conducting new human subjects research (e.g. return of identifiable results to the NIH investigator or he or she will be conducting analysis of identifiable specimens or data), prospective IRB approval of the research activity is required.

If the investigator has questions or is unable to attest to the required conditions in the form, the investigator should email julie.eiserman@nih.gov and cc: the NIH Office of IRBO (IRB@od.nih.gov) with an explanation of the situation and copies of the consent forms, if applicable.